DepoCyt for Active Lymphomatous or Leukemic Meningitis

This study has been terminated.
(Low accrual.)
Sponsor:
Collaborator:
Enzon Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00523939
First received: August 31, 2007
Last updated: June 7, 2013
Last verified: November 2012
Results First Received: February 16, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Neoplastic Meningitis
Lymphoma, B Cell
Intervention: Drug: cytarabine liposome injection

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment June 2006 - September 2008. Study stopped early due to poor accrual.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Lymphomatous Subjects with Lymphomatous Meningitis
Leukemic Subjects with Leukemic Meningitis

Participant Flow:   Overall Study
    Lymphomatous     Leukemic  
STARTED     2     2  
COMPLETED     2     2  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Lymphomatous Subjects with Lymphomatous Meningitis
Leukemic Subjects with Leukemic Meningitis
Total Total of all reporting groups

Baseline Measures
    Lymphomatous     Leukemic     Total  
Number of Participants  
[units: participants]
  2     2     4  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     2     2     4  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     0     0     0  
Male     2     2     4  
Region of Enrollment  
[units: participants]
     
United States     2     2     4  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Response Rate   [ Time Frame: 1 year ]

2.  Secondary:   Time to Neurologic Progression   [ Time Frame: 2 years ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Adverse events for both arms, lymphomatous and leukemic, were combined due to low accrual and early study termination.  


Results Point of Contact:  
Name/Title: Dr. David Rizzieri
Organization: Duke University Medical Center
phone: 919-668-1040
e-mail: rizzi003@mc.duke.edu


No publications provided


Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00523939     History of Changes
Other Study ID Numbers: Pro00009742
Study First Received: August 31, 2007
Results First Received: February 16, 2011
Last Updated: June 7, 2013
Health Authority: United States: Institutional Review Board